Method for a central venous line catheter having a temperature control system

• US 20020111584A1
• Filed: 08/24/2001
• Published: 08/15/2002
• Est. Priority Date: 04/21/1998
• Status: Active Grant

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Inventors: Barker, Peter, Walker, Blair D., Evans, Scott M., Balding, David P.
• Granted Patent: US 8,128,595 B2
• Time in Patent Office: Days
• US Class Current: 604/113
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61F 2007/0054 with a closed fluid circuit, e.g. hot water
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61F 7/123 using a flexible balloon containing the thermal element
• CPC Class Codes: A61M 1/369 Temperature treatment
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable
• CPC Class Codes: A61M 2205/36 related to heating or cooling
• CPC Class Codes: A61M 2205/366 by liquid heat exchangers
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/002 Packages specially adapted therefor combined with means for introducing catheters, e.g. dispensers, A61M25/0113; catheter kit packages for surgical articles A61B50/30
• CPC Class Codes: A61M 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 5/44 having means for cooling or heating the devices or media

Abstract

A kit of parts comprises a system and instructions for use for controlling patient temperature which uses a central venous line catheter having a heat exchange element. The central venous line catheter is provided with one or more lumens for providing access to the central blood supply of the patient, and with additional lumens for communicating heat exchange fluid to the heat exchange element. Heat exchange fluid temperature is controlled through a feed back loop in which patient temperature is sensed and used to control a temperature control unit comprising a heating device and/or a cooling device in heat exchange relationship with the heat exchange fluid. A tubing set transports the heat exchange fluid between the central venous line and the temperature control unit, with a pump serving to circulate the fluid in a closed fluid circuit in the system.

Claims

1. Method of preparing a central venous line catheter for the use, said catheter having at least one substantially elongate structure configured for establishing central venous access, said structure having a proximal portion and a distal portion and defining at least a first lumen in communication with the exterior of the elongate structure at said proximal and distal portions, and at least one heat exchange element extending at least along the distal portion adapted to effect heat exchange with the central venous system, characterized by the method step of flushing the first lumen from its distal portion to its proximal portion with sterile saline.

2. Method according to claim 1, characterized in that the volume of the flushing sterile saline is at least 5 ccm.

3. Method according to claim 2, characterized in that a 5 ccm or larger syringe is used for flushing.

4. Method according to claim 2, characterized in that injection caps are clamped to the proximal portion of the first lumen.

5. A central venous line catheter, said catheter having at least one substantially elongate structure configured for establishing central venous access, said structure having a proximal portion and a distal portion and defining at least a first lumen in communication with the exterior of the elongate structure at said proximal and distal portions, and at least one heat exchange element extending at least along the distal portion adapted to effect heat exchange with the central venous system, characterized in that the catheter is manufactured by flushing the first lumen from its distal portion to its proximal portion with sterile saline.

6. The catheter of claim 5, characterized in that the volume of the flushing sterile saline is at least 5 ccm.

7. The catheter of claim 6, characterized in that a 5 ccm or larger syringe is used for flushing.

8. The catheter of claim 6, characterized in that injection caps are clamped to the proximal portion of the first lumen.

9. Method of operating a venous line catheter system, said system having a catheter having at least one substantially elongate structure configured for establishing central venous access, said structure having a proximal portion and a distal portion and defining at least a first lumen in communication with the exterior of the elongate structure at said proximal and distal portions, and at least one heat exchange element extending at least along the distal portion adapted to effect heat exchange with the central venous system, characterized in that a heating/cooling agent at a flow rate in a range of 150-450 milliliters per minute is fed through the heat exchange element.

10. Method according to claim 9, characterized in that the flow rate is about 240 milliliters per minute.

11. Method according to claim 9, characterized in that the temperature of the heating agent is between 38°

C. and 43°

C.

12. Method according to claim 9, characterized in that the temperature of the cooling agent is between 1°

C. and 5°

C.

13. Method according to claim 9, characterized in that the heat exchanging element is a balloon.

14. Method according to claim 13, characterized in that the balloon length is about 55-60 mm.

15. Method according to claim 9, characterized in that the heat exchanging element comprises a plurality of balloons.

16. Method according to claim 15, characterized in that the balloon length is about 55-60 mm.

17. Method according to claim 15, characterized in that three balloons are disposed in a consecutive order, a first balloon having a diameter of approximately 8-12 mm, a second balloon having a diameter of approximately 5-9 mm, and a third balloon having a diameter of approximately 4-6 mm.

18. Method according to claim 13, characterized in that the wall thickness of the balloon is between 35 μ

m and 70 μ

m.

19. Method according to claim 9, characterized in that the material from which the balloon is made is selected from the group:

urethane, nylon, PE and PET.

20. Method according to claim 9, characterized in that the heat conductivity of the balloon is 0.1 to 1.5 Watt per meter x Kelvin.

21. Method according to claim 9, characterized in that the heating/cooling agent is a sterile saline.

22. A venous line catheter system, said system having a catheter having at least one substantially elongate structure configured for establishing central venous access, said structure having a proximal portion and a distal portion and defining at least a first lumen in communication with the exterior of the elongate structure at said proximal and distal portions, and at least one heat exchange element extending at least along the distal portion adapted to effect heat exchange with the central venous system, characterized by a pump feeding heating/cooling agent at a flow rate in a range of 150-450 milliliters per minute through the heat exchange element.

23. The catheter system according to claim 22, characterized in that the flow rate is about 240 milliliters per minute.

24. The catheter system according to claim 22, characterized in that the temperature of the heating agent is between 38°

C. and 43°

C.

25. The catheter system according to claim 22, characterized in that the temperature of the cooling agent is between 1°

C. and 5°

C.

26. The catheter system according to claim 22, characterized in that the heat exchanging element is a balloon.

27. The catheter system according to claim 26, characterized in that the balloon length is about 55-60 mm.

28. The catheter system according to claim 22, characterized in that the heat exchanging element comprises a plurality of balloons.

29. The catheter system according to claim 28, characterized in that the balloon length is about 55-60 mm.

30. The catheter system according to claim 28, characterized in that three balloons are disposed in a consecutive order, a first balloon having a diameter of approximately 8-12 mm, a second balloon having a diameter of approximately 5-9 mm, and a third balloon having a diameter of approximately 4-6 mm.

31. The catheter system according to claim 26, characterized in that the wall thickness of the balloon is between 35 μ

m and 70 μ

m.

32. The catheter system according to claim 22, characterized in that the material from which the balloon is made is selected from the group:

urethane, nylon, PE and PET.

33. The catheter system according to claim 22, characterized in that the heat conductivity of the balloon is 0.1 to 1.5 Watt per meter x Kelvin.

34. The catheter system according to claim 22, characterized in that the heating/cooling agent is a sterile saline.

36. Method according to claim 35, characterized by the step of withdrawing the catheter for about 2-3 cm relative to the guidewire before removing said guidewire from the catheter.

37. Method according to claim 35, characterized in that the first chemical being the same as the second chemical.

35. Method of using a central venous line catheter comprising:

at least one substantially elongate structure configured for establishing central venous access, said structure having a proximal portion and a distal portion, at least one heat exchange element extending at least along the distal portion adapted to effect heat exchange with the central venous system,

a first lumen in communication with the exterior of the elongate structure at said proximal

and distal portions, and

a second lumen through which a guidewire can extend,

characterized by the steps of

flushing a first chemical through the first lumen,

removing the guide wire from the second lumen, and

flushing a second chemical through the second lumen.